Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients

This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Miami Research Associates, Miami, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Non-Insulin-Dependent Diabetes Mellitus
Adults 21 to 79 years, inclusive
Body mass index between 30 and 40 kg/m2, inclusive

Exclusion criteria

Currently prescribed aspirin or anti-coagulants
Contraindications to aspirin
Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
Patient requires insulin

Treatment and study plan

PL2200 Aspirin Capsules

Drug

325 mg aspirin; once per day for 10 days

Enteric-coated aspirin caplets

Drug

325 mg aspirin; once per day for 10 days

Primary outcomes

Time to 99% Inhibition of Serum Thromboxane

Time frame: 11 days

Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Registry information

Official study title

Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)

Acronym: RITE

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Dec 11, 2013
Registry last updated: Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed